The following data is part of a premarket notification filed by C.a.m. Supply, Inc. with the FDA for Acupuncture Needles.
Device ID | K964861 |
510k Number | K964861 |
Device Name: | ACUPUNCTURE NEEDLES |
Classification | Needle, Acupuncture, Single Use |
Applicant | C.A.M. SUPPLY, INC. 865 S. FIGUEROA ST., SUITE 1388 Los Angeles, CA 90017 |
Contact | John N Politis |
Correspondent | John N Politis C.A.M. SUPPLY, INC. 865 S. FIGUEROA ST., SUITE 1388 Los Angeles, CA 90017 |
Product Code | MQX |
CFR Regulation Number | 880.5580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-04 |
Decision Date | 1997-05-29 |